Eligibility Criteria:
A request will be evaluated against the criteria of 21 CFR 312.305(a) and 312.310(a): a. Serious or Life-Threatening Illness: Patients must have a condition that is serious or immediately life-threatening. b. No Suitable Alternative Therapy: Patients must have exhausted other treatment options or are ineligible to participate in ongoing clinical trials. c. Favorable Benefit-Risk Assessment: The potential benefits of receiving NanO₂ must outweigh the potential risks. In evaluating requests, NuvOx will consider the totality of available information, including applicable nonclinical and clinical experience, the patient's condition, and the treating physician's rationale for use. d. Non-Interference with Clinical Development: Providing NanO₂ for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the use.